The following data is part of a premarket notification filed by Custom Medical Products, Ltd. with the FDA for Mammography Moving Grid Bucky.
| Device ID | K880905 |
| 510k Number | K880905 |
| Device Name: | MAMMOGRAPHY MOVING GRID BUCKY |
| Classification | System, X-ray, Mammographic |
| Applicant | CUSTOM MEDICAL PRODUCTS, LTD. 19A WEST INDUSTRY COURT Deer Park, NY 11729 |
| Contact | James Collette |
| Correspondent | James Collette CUSTOM MEDICAL PRODUCTS, LTD. 19A WEST INDUSTRY COURT Deer Park, NY 11729 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-02 |
| Decision Date | 1988-03-21 |